The Effects of Perioperative Painting Art Therapy (LOM® Solution Centered Art Therapy) in Surgica… (NCT04524260) | Clinical Trial Compass
UnknownNot Applicable
The Effects of Perioperative Painting Art Therapy (LOM® Solution Centered Art Therapy) in Surgical Patients
Switzerland80 participantsStarted 2020-08-31
Plain-language summary
The investigators want to study whether the use of painting art therapy has an influence on the quality of life, the complication rate and the general outcome of major abdominal surgery. The painting art therapy is carried out according to the protocol of (LOM® Solution Centered Art Therapy) by trained painting art therapists.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Consecutive adult patients of both genders ≥ 18 years subjected to major (oncological) surgery due to pathologies of the pancreatic and lower gastrointestinal tract at our department.
* The initial diagnosis does not date back longer than 6 months prior the planned surgery. Neoadjuvant radio-/chemotherapy is not an exclusion criteria.
* Able to speak and understand German or English
* Signed written informed consent by the participant after extensive oral and written information about the research project and its aims.
* Thresholds of primary outcome: anxiety levels measured with STAI-form Y-1 (state) and Y-2 (trait). Thresholds: scores between 20 (minimum) and 80 (maximum) in each subscore.
Exclusion Criteria:
* Woman who are pregnant or breast feeding.
* Known or suspected non-compliance regarding the execution of painting art therapy and/or the proper completion of the needed forms.
* Drug or alcohol abuse.
* Regular intake of antidepressant medication with the exception of medication prescribed for chronic insomnia.
* Acute suicidality.
* Life expectancy less than 9 months after planned surgery.
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, ect. of the participant
* Participation in another study during the present study and within 6 weeks following the surgery.
* Previous enrollment into the current study.
* Enrollment of the investigator, his/her family members, employees and…
What they're measuring
1
Change of Anxiety
Timeframe: Change from Baseline STAI-Score up to 6 months post surgery